Pharmacokinetics in Drug Development - for the Non-Specialist

01 Jul 2013 - 02 Jul 2013 - London, UK

In drug development clinical pharmacology is tasked to ensure that patients receive the right dose at the right time. This ensures that the new medicine is safe and effective throughout the patient population. To achieve this goal, it is necessary to recognise the factors that can alter drug response. Knowledge of pharmacokinetics (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationships is at the heart of this endeavour. For many drugs, clinical pharmacology information accounts for almost 50% of the final drug label, further emphasising the importance of PK understanding in drug development.

Course Objectives

To provide participants with an overview of the principles of Pharmacokinetics and Pharmacokinetic/Pharmacodynamic modelling and how, together with regulatory guidances, they can be used to effectively deliver drug development programmes

What will participants gain-

Increased confidence to discuss PK issues within their drug projects

Understanding of the common PK terms and their importance

Understanding of how PK data influences the clinical development programme

An understanding of the factors that contribute to variability in PK

The role of PK/PD modelling in drug development

An appreciation of how regulatory guidances influence PK

Who Should Attend?

The course is intended for all professionals in the drug development arena especially those that work in or with clinical project teams (eg Regulatory Affairs specialists; Medical personnel; Project managers/leaders; Clinical research associates, Medical writers) who want to further their knowledge of the usefulness of PK in their projects.

Numbers are restricted for maximum benefit to participants

Course Programme

Course will commence with registration at 8.30am, course proper at 9.00am and will finish at 5.00pm each day.

Day 1: Pharmacokinetic Principles

The principle processes involved in PK will be discussed and the jargon used in their description and quantification will be explained.

What is PK and why is it important

Absorption, distribution, metabolism and elimination

Therapeutic windows

PK terminology

Clearance, Volume of distribution

PK techniques

Non compartmental Analysis

Compartmental modelling

PK/PD modelling

Regulatory environment

Data interpretation

Reporting

Day 2: PK in Drug Development

The application of PK in clinical development will be addressed by looking at questions that commonly arise within drug projects. Examples include: "What are the implications of pre-clinical PK findings on the design of early phase development studies"; "How is the clinical relevance of a drug drug interaction assessed" and "What are the sources of variability in pharmacokinetic response".